Dapagliflozin Therapy In Cardiac Surgery

China National Center for Cardiovascular Diseases178 enrolled

Overview

This randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing cardiac surgery

Sodium-Glucose Cotransporter 2 Inhibitor(SGLT2i) including dapagliflozin are widely used in the clinical treatment of type 2 diabetes mellitus(T2DM). In recent studies, SGLT2i were found to not only reduce blood glucose but also protect the heart and kidney, which can significantly reduce cardiovascular events, delay the progression of renal failure, greatly improve the quality of life of patients. Patients with T2DM have poorer cardiac surgery outcomes compared with non-diabetics. Based on the promising pharmacological profile of dapagliflozin, we hypothesize that perioperative dapagliflozin therapy would improve postoperative outcomes among patients undergoing cardiac surgery with T2DM. This randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing cardiac surgery

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

178

Conditions

Diabetes Mellitus, Type 2 Cardiac Surgery

Interventions

DapagliflozinDRUG

The patients is required to receive dapagliflozin(10mg, q.d.) at least for 3 days until 24 hours before the surgery. Then dapagliflozin will be discontinued and recovered as soon as the patient is able to take oral diet postoperatively. Dapagliflozin wil be ceased five days after surgery.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 18 years at screening 2. Scheduled for cardiac surgery (on-pump coronary artery bypass grafting, aortic valve replacement, or a combination of both) 3. Diagnosis of Type 2 Diabetes 4. Provision of signed informed consent prior to any study specific procedures Exclusion Criteria: 1. Emergency surgery and non-primary surgery 2. Moderate and severe dehydration; systolic pressure≤90mmHg; unstable haemodynamics 3. History of diabetic ketoacidosis; type 1 diabetes mellitus 4. Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to enrolment 5. Known allergy or hypersensitivity to dapagliflozin or other SGLT-2 inhibitors 6. Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 or requiring dialysis; unstable or rapidly progressing renal disease at the time of randomisation 7. Serious hepatic disease 8. Women who are pregnant, nursing, or who plan to become pregnant while in the trial 9. Currently enrolled in another investigational drug study, or less than 30 days

Locations (1)

National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Hs-Troponin-I

high sensitive cardiac troponin-I

Time frame: within 2 days after surgery

Secondary Outcomes

Renal function

Acute kidney injury determined by creatinine changes and the need for renal replacement therapy, along with creatinine changes and the need for renal replacement therapy themselves.

Time frame: within 5 days after surgery

NT-proBNP

N-terminal prohormone of brain natriuretic peptide

Time frame: within 5 days after surgery

Postoperative atrial fibrillation

In this study, postoperative AF was defined as occurrence of the arrhythmia within the first 5 days after cardiac surgery. AF was considered to be present when an irregular rhythm was detected in the absence of P waves and/or presence an f wave

Time frame: within 5 days after surgery

Perioperative myocardial infarction

Perioperative myocardial infarction was defined as an elevation in cardiac troponin accompanied by evidence of ischemia from ECG, angiographic, or imaging findings.

Time frame: In-hospital time, an average of 2 weeks

cardiac systolic function

Improvement in either left ventricular ejection fraction or left ventricular end-systolic volume, as measured by echocardiography.

Time frame: within 5 days after surgery

cardiac diastolic function

Improvement in either E/e' ratio or left ventricular end-diastolic volume, as measured by echocardiography.

Data from ClinicalTrials.gov

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